George Mason University (GMU) proposes construction of an 83,154 square foot Regional Biocontainment Laboratory (RBL) designed to support the research objectives of the National Institute of Allergy and Infectious Diseases (NIAID) for biodefense. The overall research program will focus on the development of animal models, host-pathogen relationships, aerobiology, and testing of vaccines and therapeutics against aerosol challenge in a Good Laboratory Practices (GLP) environment. In addition to research, a training program will be established for aerobiology and high- containment animal research. The facility, designed for maximum flexibility, will incorporate Biosafety Level (BSL)2 and BSL3 laboratories, with supporting animal research laboratories, aerobiology suites, a vivarium for small animals andnon- human primates, necropsy room, and associated support spaces. Key strengths that GMU brings to this effort are its internationally known experts in biological defense; proposed key personnel with national reputations and extensive experience in biological defense, aerobiology, bacteriology, virology, and animal model development; its location in the Washington, DC metropolitan area; and its collaborative relationships with the U.S.Army Medical Research Institute for Infectious Diseases, other Federal agencies, and elements of private industry engaged in biodefense research. In the event of a national bioterrorism emergency, the proposed RBL will offer surge laboratory capacity, trained laboratory personnel, and expert consultation to local, regional, state, and national entities involved in first response and biological incident management. The RBL administrative core will direct and prioritize all activities with the aim of assisting NIAID- funded biodefense investigation from institutions lacking appropriate biocontainment facilities, technology, or training. Principal Investigator: Bailey, Charles L. 5. BUDGET (ADDITIONAL INFORMATION REQUIRED) 5.0. Composition of Applicant-Provided Matching Funds (Form 424, item 15b) GMU has completed a Teaming Agreement with TRex Capital (Appendix 1) and received a Letter of Intent from TRex Capital (Appendix 2) which states that, should GMU be awarded $25 million by the National Institutes of Health (NIH) and subject to federal and state procurement regulations, GMU will purchase the proposed Regional Biocontainment Laboratory from TRex for a total of $40.3 million. A total of $25 million will be paid to TRex upon completion and commissioning of the facility, with the $15.3 million balance paid over 20 years. This represents a $15.3 million cash contribution from the University as matching funds. TRex has obtained a letter of credit from national lender Lehman Brothers for $17 million (including $1.8 million for land cost) (see appendix 3 for letter of credit). Therefore, at the time of the award, TRex, on behalf of GMU, will have the entire $15.3 million available. GMU's letter documenting the availability of the matching funds is in appendix 4. In the Commonwealth's 2004 Budget, GMU was granted authority by the Virginia General Assembly to enter into a 20-year capital lease for a BSL3 animal facility (appendix 5). This authority allows the University to ask the Department of Planning and Budget to issue bonds, and GMU maintains the right to do so should market conditions warrant. GMU anticipates paying back TRex out of the indirect costs charged on grants and contracts for research performed in the RBL facility, but is fully prepared to meet this obligation from alternative funding sources, for example other indirect cost accounts within the College of Arts & Sciences, in any period in which insufficient indirect costs are generated by work conducted in the facility. GMU does not plan to use other cash, pledges, or contingent gifts or bequests as part of the applicant-provided matching funds. $25,000,000 award from NIAID $15.300.000 cash match borrowed by TRex from Lehman Brothers on behalf of GMU $40,300,000 award plus matching funds [unreadable] GMU's Board of Visitors has indicated its support for the proposal, and the cost of a capital lease for such a project is included in the University's 6-year Capital Improvement Plan (see outline of Capital Improvement Plan and letter of support from University Rector in appendix 5). Upon commissioning, the animal BSL (ABSL)3 portion of the facility is projected to generate more than $7 million in indirect costs to GMU annually when fully occupied. With six animal rooms and three aerosol biology lines, the ABSL3 portion'of the facility is designed for maximum flexibility to be as responsive as possible to researchers' needs. This configuration will permit studies with multiple species of animals, multiple select agents, and multiple potential therapies, diagnostics, and/or vaccines at the same time. Further flexibility is provided by four additional animal rooms in the BSL2 [unreadable]portion 'of the facility, allowing work that does not involve aerosols and does not require BSL3-level containment. These four ABSL2 rooms are projected to generate more than $5 million in indirect costs annually at full capacity. Taken as a whole, the ten animal rooms in the facility will generate enough overhead dollars to cover the annual debt payments when operating at approximately 35% capacity. The facility will also include two BSL3 laboratories and two BSL2 laboratories for non-animal work; these labs will also be expected to generate sponsored research that will help defray costs. 5.1. Sources of Funds Necessary to Complete Total Project and Their Availability As part of the Teaming Agreement described above, GMU has agreed to purchase from TRex the 8.3-acre site on which the facility will be built. The $1.8 million cost of the land will be paid by GMU over twenty years (see model purchase/capital lease agreement, appendix 6). Recognizing the sizable start-up costs associated with this new facility, the Chief Financial Officer and the Provost have authorized GMU Life Sciences to retain all of the overhead dollars generated by National Center for Biodefense (NCBD) research grants and contracts between the time of the award and one year post commissioning of the facility. This amount is estimated at $1.9 million for calendar year 2005 and is expected to increase based on proposals submitted and the previously approved hiring of new faculty who will bring existing funded research programs. Retaining these dollars in the early period of the award, when training and equipment costs will be low, will ensure their availability in the later stages of the startup process when these expenses will be higher but the facility will not yet be generating revenue. Considering a year for redesign and two years for construction, this start-up contingency fund should provide between $4 and 6 million for movable equipment and training costs. GMU has entered into a Cooperative Research and Development Agreement and is establishing an Educational Partnership Agreement with the US Army Medical Research Institute of Infectious Disease (USAMRIID) that will allow USAMRIID staff to provide training in aerobiology and BSL3 animal handling to GMU personnel prior to opening of the facility (see appendix 7). The cost of movable equipment required to be purchased prior to commissioning of the facility (approximately 4% of the planned construction cost of $29 million) is estimated to be $1.2 million . Additionally, while it is expected that the salaries of most of the facility's staff will be covered as direct costs on grants and contracts, GMU recognizes that hiring and training of the technical staff will begin well before the facility is operational. The Provost and Chief Financial Officer have committed the University to pay these costs as appropriate should they exceed the balance of the start-up contingency fund.